SwissTEC SL Bond - Coltène/Whaledent AG

Duns Number:480017482

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More Product Details

Catalog Number

5640

Brand Name

SwissTEC SL Bond

Version/Model Number

5640

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2021

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K974906

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

afc9588d-6cfb-4987-8c9e-bcf60c641e8a

Public Version Date

October 20, 2021

Public Version Number

4

DI Record Publish Date

August 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLTÈNE/WHALEDENT AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1524
2 A medical device with a moderate to high risk that requires special controls. 960